Events

Alerte De Sécurité sur ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, 1003838260, 1003848040, 1003883560, 1003990940, 1004089920.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Biomerieux Brasil SA.; Biomerieux S. A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1746
  • Date
    2015-11-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to the company the problem may cause a failure to control the calibration of the Densimat instrument, potentially leading to false susceptibility or false identification results. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • Cause
    Performance failure, with change in performance, in the lots described for the product atb- densitometer control device. in this case, the calibration check of the densimat equipment may fail.
  • Action
    The company will collect and destroy the products. A letter will be forwarded to all customers who have purchased the affected lots, with detailed guidance on how to proceed with the product covered by this field action. The company directs you to stop using the affected product and fill out the Notification form to notify the company of any remaining stock of the kit. The company's recommendation is that until the manufacturing of new lots, the Mc Farland standard scale can be used as a back-up solution. A new batch of the product was released to replace the nonconforming product. Additional batches will be available for allocation until the breach situation is resolved. As soon as stock is normalized, bioMérieux will contact customers.

Device

ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, ...

Manufacturer

Biomerieux Brasil SA.; Biomerieux S. A